Robot-assisted Arm Training in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— RAMSES  

Official title:

Effects of High-intensity Robot-assisted Training in Hand Function Recovery and ADL Independence in Individuals With Multiple Sclerosis: a Randomized Controlled Single-blinded Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561155
• Other study ID #: FISM 14/14/F14
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: May 1, 2018

Study information

• Verified date: June 2018
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The upper limb (UL) plays an important role in the daily functioning of patients with Multiple Sclerosis (MS) and negatively influences their quality of life. Effective arm-hand training programs are needed. Various robotic systems have been developed for UL rehabilitation, mainly used in patients with stroke. Preliminary work in MS has focused on proximal sections of the arm. No study has evaluated the use of robotics for improving manual dexterity and their effects on cortical activity. The results of this research project could be relevant for the advancement of knowledge about UL functional recovery in individuals with MS and to determine the pattern of muscle activation underlying functional recovery.

Description:

Studies regarding the effectiveness of conventional and robot-based upper limb (UL) rehabilitation in individuals with MS is very limited.In the last 15 years, conventional rehabilitation of the UL in patients with neurological disorders has been enriched by the development of robots as they can provide high-intensity, repetitive, interactive and task-specific exercises.They are increasingly used in rehabilitation after stroke, therefore may also be good candidates for neuromotor rehabilitation of patients with MS. Furthermore, these devices can provide various feedbacks that can guide patients during the sensorimotor training and allow quantitative measurement of motor performance during training.One of these devices is the Amadeo®, a modern, mechatronic end-effector robotic device designed to improve sensorimotor functions in patients with restricted movement in individual fingers or in the entire hand.Another important issue concerns cortical plasticity, which plays a fundamental role in motor learning and neurorehabilitation.To date, the specific mechanisms leading to UL recovery after neurological rehabilitation are still unclear.The development of new EEG instruments allows brain activity to be tested under specific rehabilitation tasks contributes to give new insight in the dynamics of cortical networks reorganization promoted by rehabilitation.The main aim of the study is to perform a single blind RCT on 60 outpatients with MS (age:18-65 years;EDSS<8) in order to compare the efficacy of high-intensity robot-assisted training with conventional treatment on sensorimotor hand recovery, disability in ADLs and QoL.The secondary aim is to explore the underlying neuronal mechanisms of UL recovery by using EEG investigations and innovative robotic equipment. 10 controls (age 18-65 yrs) will undergo one session of the same Video-EEG acquisition to collect normative data to compare with data collected on patients.Each participant will receive 40-minute sessions over an 8 week period (3 days/week). Each session will consist of 30 minutes of hand training and 10 minutes of passive upper limbs mobilization.The experimental group will receive robot-assisted therapy by Amadeo.The control group will receive conventional rehabilitation.Before treatment, immediately after treatment, 1 month after treatment patients will be evaluated with a comprehensive protocol of all ICF domains as well as acquisition by Video-EEG acquisition combined with Amadeo® robotic training device.Primary outcome measures:Fugl-Meyer Assessment Motor Scale.Secondary measures: UL electromyographic analysis,Tremor Severity Scale, Nine Hole Peg Test, Amadeo® hand muscle strength (Newton), Motricity Index, Visual anolgue Scale for tiredness and fatigue; TEMPA, Motor Activity Log, Action Research Arm test, Multiple Sclerosis Quality of Life-54 and the assessment of Life Habits. Parametric tests and nonparametric tests will be performed according to variable distribution (p<.05)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 1, 2018
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age: 18-65 years

• EDSS score<8

• Mini Mental State Evaluation (MMSE) score>24

• Ashworth Scale Score<2 evaluated at the elbow, wrist and fingers

• Nine Hole Peg Test (NHPT) score >30 sec.

Exclusion Criteria:

• Disease recurrence that worsened significantly during the 3 months prior to recruitment

• Medical therapy not well defined

• Musculoskeletal impairments or excessive pain in any joint that could limit participation in an exercise program

• Severe visual dysfunction

• Performance of any type of rehabilitation treatment in the month prior to recruitment

• Other concomitant neurological or orthopaedic diseases involving the UL and interfering with their function

Related Conditions & MeSH terms

• Multiple Sclerosis
• Rehabilitation
• Sclerosis

Intervention

Device:
• Robot assisted treatment (Amadeo®)
The protocol will consist of exercises as follows: passive modality , passive/plus modality , assisted therapy and Balloon.

Other:
• Conventional treatment
The protocol will consist of exercises as follow: upper limb mobilization, facilitation of movements and active tasks. The exercises will be focused on improving muscle strength, finger extension and flexion and motor control

Locations

Country	Name	City	State
Italy	UOC Neurorehabilitation	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Arm test	Assesses upper limb functioning using observational methods	Up to 6 weeks
Secondary	Fugl-Meyer Assessment Motor Scale - Arm Section	Evaluates and measures recovery in post-stroke hemiplegic patients	Up to 6 weeks
Secondary	Motor Activity Log	Semi-structured interview to assess arm function.	Up to 6 weeks
Secondary	Tremor Severity Scale	A clinical rating scale which measured the severity of tremor	Up to 6 weeks
Secondary	Nine Hole Peg Test	Measures finger dexterity	Up to 6 weeks
Secondary	Motricity Index	Measures of strength in upper limb	Up to 6 weeks
Secondary	Amadeo® hand muscle strength (Newton)	Measures of muscle strenght using the robotic device	Up to 6 weeks
Secondary	Visual anolgue Scale for tiredness and fatigue	Measures of tirediness and fatigue on a 10-point likert scale	Up to 6 weeks
Secondary	Multiple Sclerosis Quality of Life-54	Measures of a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument.	Up to 6 weeks
Secondary	Assessment of Life Habits	Assesses participants on 77 life habits from daily activities to social participation across 12 domains.	Up to 6 weeks
Secondary	UL electromyographic analysis of muscle activation	Instrumental assessment of muscle activity during a reaching task	Up to 6 weeks